Protocol for Multi-site Evaluation of New Community-based Frailty Programme

Frailty Clinical Trial

Official title:

Protocol for a Mixed Methods and Multi-site Assessment of the Implementation Process and Outcomes of a New Community-based Frailty Programme

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04866316
• Other study ID #: 2019/00925
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: September 30, 2022

Study information

• Verified date: August 2022
• Source: Geriatric Education and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background: Frailty is increasing in prevalence internationally with population ageing. Frailty can be managed or even reversed through community-based interventions delivered by a multi-disciplinary team of professionals, but to varying degrees of effectiveness. However, many of the implementation insights of these care models are contextual, and may not be applicable in different cultural contexts. The Geriatric Service Hub (GSH) is a novel frailty care programme in Singapore, that includes key components of frailty care such as comprehensive geriatric assessments, care coordination and the assembly of a multidisciplinary team. The aim of this study is to gain insights on the factors influencing the implementation approaches adopted by five participating sites, and the effectiveness of the programme.

Methods: We will adopt a mixed-methods approach that includes a qualitative evaluation among key stakeholders and participants taking part in the programme, through in depth-interviews and focus group discussions. The main topics covered includes factors that affected the development and implementation of each programme, operations and other contextual factors that influenced implementation outcomes. The quantitative evaluation (1) monitors each programme's care process through quality indicators, (2) a multiple-time point survey study to compare programme participants' pre- and post- outcomes on patient engagement (collaboRATE and 13-item Patient Activation Measure;PAM), healthcare experiences (Consumer Assessment of Healthcare Providers and System Clinician and Group Survey Version 3.0; CG-CAHPS), health status and quality of life (Barthel Index of Activities of Daily Living, fall counts, the EuroQol questionnaire and the Control, Autonomy, Self-realization and Pleasure scale; CASP-19), impact on caregivers (Zarit Burden Interview) and societal costs (Client Service Receipt Inventory). (3) A retrospective cohort design to assess healthcare and cost utilisation between participants of the programme and a propensity score matched comparator group.

Discussion: The GSH sites share a common goal to increasing accessibility of essential services to frail older adults, and providing comprehensive care. The results of this evaluation study will provide valuable evidence to the impact and effectiveness of the GSH, and inform to the design of similar programmes targeting frail older adults.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 335
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

1. Qualitative In depth Interviews/ Policy owners & administrators

Inclusion Criteria:

• Decision-makers who are higher-level administrators or clinicians who have the authority to make policy and implementation decisions and/ or

• Individuals who are familiar with the hospital's overall frailty strategy; and/ or

• Individuals that who led the development and implementation of the programme

Exclusion Criteria:

• Do not meet inclusion criteria above

2. Qualitative Focus group discussions/ Implementation team

Inclusion Criteria:

• Individuals with time funded through the programme who have been providing services in the GSH for at least six month

Exclusion Criteria:

• Do not meet inclusion criteria above

3. Qualitative Focus group discussions/ partner organizations

Inclusion Criteria:

• healthcare professionals and administrative staff who provided services within the new programme for at least six months

Exclusion Criteria:

• Do not meet inclusion criteria above

4. Qualitative Focus group discussions/ GSH participants

Inclusion Criteria:

• Participants who receive care under the new model for at least three months

Exclusion Criteria:

• Do not meet inclusion criteria above

5. Quantitative survey questionnaire / GSH participants

Inclusion Criteria:

• Patients that meet the necessary clinical criteria for enrollment in the respective GSH programme

• Age: 65 and above

• Clinical Frailty Score (CFS): 4-7

Exclusion Criteria:

• Do not meet inclusion criteria above

Related Conditions & MeSH terms

• Frail Elderly Syndrome
• Frailty
• Frailty Syndrome
• Syndrome

Intervention

Other:
• There is no active intervention as this is a service evaluation
There is no active intervention as this is a service evaluation

Locations

Country	Name	City	State
Singapore	Geriatric Education and Research Institite	Singapore

Sponsors (6)

Lead Sponsor	Collaborator
Geriatric Education and Research Institute	Alexandra Hospital, Changi General Hospital, Ng Teng Fong General Hospital, Sengkang General Hospital, Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional status	It is hypothesised that better functional status, might reduce the healthcare utilisation (emergency hospitalisation, nursing home admission), caregiver burden and the associated indirect cost. In turn, we might expect overall costs to be lower compared to the comparison group.; Changes in functional status will be measured using the Barthel Index of Activities of Daily Living (ADL) and Count of falls questionnaire.	April 2019 - September 2022
Primary	Health outcomes	It is hypothesised that better health outcomes, might reduce the healthcare utilisation (emergency hospitalisation, nursing home admission), caregiver burden and the associated indirect cost. In turn, we might expect overall costs to be lower compared to the comparison group.; Health outcomes will be measured using Quality of Life Questionnaire (EuroQol-5D-5L) and 19-item Quality of Life Scale (CASP-19).	April 2019 - September 2022
Secondary	Utilisation of appropriate services	GSH sites offer a range of medical, social and other services through either direct provision or referrals. Given that the model is intended to bridge service gaps (conduct of Comprehensive Geriatric Assessment/ CGA in the community), in the short-term, we hypothesis an increase in the utilisation of appropriate services (rehabilitation, ambulatory services) in this time-limited programme.; Utilisation of services will be measured using Client Service Receipt Inventory (CSRI).	April 2019 - September 2022
Secondary	Patient Satisfaction	GSH participants are expected to benefit from the comprehensive package of health and social services and multidisciplinary team approach. With better care coordination and improved access, it is likely to elicit a higher level of satisfaction relative to comparator groups.; Patient satisfaction will be measured using the Consumer Assessment of Healthcare Providers and System Clinician & Group Survey Version 3.0 (CG-CAHPS) tool.	April 2019 - September 2022
Secondary	Shared decision making/ engagement	Education of the client about self-care, and making decisions about potential care options with inputs from a multidisciplinary team, is expected to result in higher level of shared decision making and engagement relative to comparator groups.; Shared decision making/ engagement will be measured using the collaboRATE For Patient - 5-point anchor scale, and 13-item Patient Activation Measure (PAM-13).	April 2019 - September 2022